C-TRACTCatheter-Directed Therapy for Chronic Venous Thrombosis Relief
The main goal of this study is to evaluate how catheter-directed therapy combined with standard treatment affects post thrombotic syndrome severity in patients with chronic venous thrombosis and iliac vein obstruction.
Stents
Cardiovascular Diseases+10
+ Leg Ulcer
+ Skin Diseases
Treatment Study
Summary
Study start date: July 2, 2018
Actual date on which the first participant was enrolled.This study focuses on finding better ways to treat a condition called Deep Iliac Obstruction-Post Thrombotic Syndrome (DIO-PTS), which severely affects people's lives. Current treatments don't work well for everyone, and some options are risky and costly. The study looks at a new method called Endovenous Therapy (EVT), which uses procedures like stent placement and ablation to improve blood flow in the veins. The goal is to see if this method can be safely used more often to relieve symptoms and improve quality of life for those with DIO-PTS. The study aims to provide clear answers on whether EVT should become a standard treatment practice or not. In the study, 250 participants with DIO-PTS are divided into two groups: one receiving EVT and the other continuing with standard treatment alone. EVT involves procedures such as inserting a small mesh tube to keep the vein open and using heat to close off problematic veins. All participants will receive the usual care for DIO-PTS as well. The effectiveness of the treatments will be evaluated by measuring changes in the severity of the symptoms after six months. Participants’ health and progress will be monitored for either 6 or 24 months, depending on when they joined the study. This will help determine whether EVT is a valuable addition to current treatment options.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.225 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 29 locations
St. Joseph's Vascular Institute
Orange, United StatesOpen St. Joseph's Vascular Institute in Google MapsUCSF
San Francisco, United StatesYale New Haven Hospital
New Haven, United StatesChristiana Care Hospital
Newark, United States